BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA SR

    MDR report key: 1902801 · Received November 18, 2010

    Report

    Report Number
    2647346-2010-00735
    Event Type
    Death
    Date Received
    November 18, 2010
    Date of Event
    May 22, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED LESS THAN 6 MONTHS AFTER DEVICE WAS IMPLANTED. FOLLOW UP WITH THE CLINIC REPORTED THE DEATH WAS NOT DEVICE RELATED. THE CAUSE OF DEATH WAS PANCREATIC CANCER. PATIENT LAST DEVICE CHECK HAD BEEN APPROXIMATELY SEVEN WEEKS PRIOR TO DEATH AND THE DEVICE CHECKED OUT FINE. PATIENT LAST SEEN IN OFFICE A WEEK AFTER THAT FOR BLOOD WORK. THE PATIENT THEN WENT INTO HOSPICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED LESS THAN 6 MONTHS AFTER DEVICE WAS IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA SR ASKU NVZ MEDTRONIC MED REL, INC. SESR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death COMPETITOR IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE PACING LEAD